MedTrace Logo

Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Trial

NCT01784887 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-08-03

No results posted yet for this study

Summary

Utilizing wound healing trajectory analysis, patient-reported pain and QOL assessment, quantitative bacteriology, and inflammatory infiltrate quantification, an improvement in wound healing will be observed on a cellular, histomorphological and clinical level in the presence of a bioelectric dressing applied in conjunction with SOC.

Conditions

  • Non-healing Soft Tissue Wounds

Interventions

DRUG

Procellera

PROCELLERA TM is an FDA-cleared bioelectrical dressing delivered in a sterile, single layer sheet consisting of a flexible polyester fabric layer containing silver and zinc, which are held in position on the polyester with a biocompatible binder.

Sponsors & Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01784887 on ClinicalTrials.gov